The ACCESSIT Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Mechanical Ventilation.
- Кому может быть актуально
- Состояния в реестре: Respiratory Support. Базовые параметры: от 16 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Role of ACCESsory Muscles in Mechanically Ventilated Patients After Spinal Cord Injury and Trauma: a Physiological Study - The ACCESSIT Study
Обзор
The study is designed to characterize and monitor the structure, degree of activation and function of the different respiratory muscles during mechanical ventilation after spine trauma and spinal cord injury.
Подробное описание
In patients with spinal cord injury, separation from mechanical ventilation is an essential aspect of the prognosis. Denervation of specific muscles, as a consequence of the injury, can generate a dysfunction of the involved muscles and/or a disruption of their coordination during breathing. Respiratory muscle dysfunction is strongly associated with failure of weaning from mechanical ventilation. However, the pattern of activation and coordination of the different respiratory muscles, as well as their evolution over time, have been poorly investigated in spinal cord injury, particularly during the acute phase in intensive care unit.
Assessing the structure, activity, and function of the respiratory muscles at different time points after the injury would help to better understand the natural course of respiration in these patients and the possible therapeutic approaches. In fact, depending on the activation/deactivation and residual function of the respiratory muscles, there might be potential for recovery and training, with the possibility of improving patients' clinical outcomes.
In this preliminary physiological study, the investigators aim to assess the feasibility of monitoring non-invasively the respiratory muscles in mechanically ventilated adult patients with traumatic spine lesion, with and without spinal cord injury. The investigators also aim to assess, monitor, and compare over time the structure, degree of activation, function, and coordination of the different respiratory muscles.
Because the diagnosis of spinal cord injury is not always made immediately in spine trauma patients, and because other factors related to chest or abdominal trauma could interfere with the respiratory pattern, the plan is to study and follow patients with spinal cord injury, using patients with traumatic spine lesion without spinal cord injury as controls.
Вмешательства
- Другое Mechanical Ventilation
Patients will be assessed and measurements will be taken during controlled ventilation (most likely \<72 hours of ICU admission), during partially assisted ventilation, and until spontaneous unassisted breathing is reached.
Первичные конечные точки
- Thickness and thickening fraction of the accessory muscles and their evolution over time during mechanical ventilation after spinal cord injury and spine trauma. [Срок оценки: Baseline measurements assessed ≤ 72 hours from admission and subsequent measurements assessed > 72 hours from intensive care unit admission, until spontaneous unassisted breathing is reached, up to 6 weeks from enrollment]
Вторичные конечные точки (2)
- Timing of activation and coordination of the diaphragm and of the different accessory muscles will be assessed using surface electromyography and monitored over time, after spinal cord injury and spine trauma. [Срок оценки: > 72 hours after intensive care unit admission up to 6 weeks from enrollment]
- Rib cage and abdomen displacement and their coordination will be recorded and monitored over time using respiratory inductive plethysmography, after spinal cord injury and spine trauma. [Срок оценки: > 72 hours after intensive care unit admission up to 6 weeks from enrollment]
Критерии участия
Критерии включения
- Presence of traumatic spine lesion (with and without spinal cord injury)
- Requiring invasive mechanical ventilation, via oro-tracheal or tracheostomy tube,
- 16 years of age or older
- Patient or substitute decision maker able to provide consent
Критерии исключения
- Expected withdrawal of treatments within 24 hours of screening
- Chronic respiratory failure already treated with mechanical ventilation before the injury
- Documented pre-existing neuromuscular diseases
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Канада · 1 центр
- Unity Health Toronto - St. Michael's Hospital — Toronto
Публикации
- Schreiber AF, Vieira F, Madotto F, Sousa MLA, Rodrigues A, Ko M, Phoophiboon V, White McFarlan A, Brault C, Subira C, Singh JM, Reid WD, Rigamonti A, Baker A, Witiw CD, Brochard LJ. Respiratory muscle activity and weaning from mechanical ventilation after spinal trauma: the ACCESSIT study. Ann Am Thorac Soc. 2026 Jun 1;23(6):927-940. doi: 10.1093/annalsats/aaoag046. PMID 41723830
Идентификаторы
NCT: NCT05207046 · 21-226